Kornimate/medical-research-clean huggingface dataset:
wearable cardioverter defibrillator in hemodialysis patients (wed-hed) study

Conditions: Sudden Cardiac Death; Sudden Cardiac Arrest

Summary: a multi-center, prospective, randomized controlled clinical trial with 1:1 assignment of treatment and control. this study will evaluate the impact of wearable cardioverter defibrillator use on sudden cardiac death in incident hemodialysis patients. the study will enroll up to 2,600 subjects. a maximum of 200 sites in the usa will be used for enrollment.

objective: to study the impact of wearable cardioverter defibrillator (wcd) use on sudden cardiac death in hemodialysis patients. study population: participants will be patients beginning hemodialysis (\<2 months from initiation) who are ≥ 50 years old. intervention: a wcd will be used for protection against sudden cardiac death (scd). study design: the study will be a multi-center, prospective, randomized controlled trial with 1:1 assignment of treatment and control. study size: the study will enroll up to 2,600 subjects. a maximum of 200 sites will be used for enrollment.

Eligibility criteria:
inclusion criteria: * end stage renal disease (esrd) requiring hemodialysis * on hemodialysis for ≤ 2 calendar months or scheduled to begin hemodialysis within 1 calendar month * ≥50 years of age * documented ejection fraction \> 35% within the previous calendar year * - if the patient has been hospitalized for a myocardial infarction or heart failure decompensation, the ejection fraction measurement must have occurred during the last hospitalization or after discharge exclusion criteria: * is receiving or will receive hemodialysis due to acute kidney injury and is not expected to receive subsequent chronic hemodialysis therapy * patient has an active icd * patient has a unipolar pacemaker * patient has physical or mental conditions preventing him/her from interacting with or wearing a wearable cardioverter defibrillator * patient has a chest circumference at the level of the xiphoid of \< 24 inches * patient has a chest circumference at the level of the xiphoid of \> 56 inches * patient has an advance directive prohibiting resuscitation * patient has cancer or other terminal disease (excluding esrd) with expected survival less than 6 months * patient is medically unstable for reasons not specifically related to kidney disease * patient is scheduled for live-donor kidney transplantation within 6 calendar months * patient is unable to consent

Keywords: ventricular tachycardia
lay health advisors for sexually transmitted disease prevention

Conditions: Syphilis; Gonorrhea; Chlamydia Infections; HIV Infections

Summary: non-professional community leaders may be at a great advantage in reaching otherwise hard to reach populations for the purpose of advising on sexually transmitted disease (std) prevention (lay health advisors), health care access, and model health behavior. latino migrant farm workers are at increased risk for std and might benefit from such lay health advisors. the study will examine whether this strategy is a useful one for std prevention in latino migrant farm workers in rural and small town areas of north carolina.

this is a demonstration project which includes the development, implementation, and evaluation of hombres: hombres manteniendo bienestar y relaciones saludables (men maintaining wellness and healthy relationships). applying a community-based participatory research (cbpr) approach, this 3-year study uses a quasi-experimental delayed-intervention comparison group design to assess the feasibility of implementing and the potential efficacy of an adult soccer league-based lay health advisor intervention. the intervention is designed to: reduce sexual risk behaviors among latino seasonal farmworkers; enhance access to sexually transmitted disease/hiv healthcare services; and develop effective data collection methods among latino men.

Eligibility criteria:
inclusion criteria: lha (lay health advisor) and participants: * to be eligible for participation in this study as a lay health advisor (lha), an lha must: 1. self-identify as latino or hispanic; 2. work as a migrant or seasonal farmworker; 3. be a member of the liga hispana de fútbol de nc; 4. be 18 years of age; 5. be literate in spanish; and 6. provide informed consent. exclusion criteria: * based on the characteristics of the league population, the researchers anticipate that few potential lhas or participants will be excluded.

Keywords: latino lay health access prevention hiv seronegativity hiv
fidaxomicin versus standard of care therapy in solid organ transplant recipients with clostridium difficile infection

Conditions: Clostridium Difficile Infection; Solid Organ Transplant

Summary: a prospective study to assess the efficacy and safety of fidaxomicin in solid organ transplant (sot) recipients (heart, lung, kidney, liver, kidney-pancreas, and pancreas) with a first-episode of clostridium difficile infection (cdi).

patients will be treated with fidaxomicin 200 mg po twice daily for 10 days. the rate of sustained clinical response (scr; cure without recurrence at 30 days) will be assessed and compared to a historical cohort of sot recipients who received standard of care therapy for cdi at our institution. the data for the historical control group will be collected under a separate irb-approved protocol. standard of care therapy will be considered oral or intravenous metronidazole and / or oral vancomycin. the study will be powered to show non-inferiority of fidaxomicin compared to standard of care treatment in sot recipients.

Eligibility criteria:
inclusion criteria: * age 18 or greater and up 85 years * sot recipient (lung, heart, kidney, liver, kidney-pancreas, pancreas) * first episode of cdi exclusion criteria: * receiving additional therapies with activity again c. difficile (oral bacitracin, fusidic acid, and/or rifaximin) * toxic megacolon * ileus or significant abdominal distension * hypotension with vasopressor requirement * history of inflammatory bowel disease * pregnancy * decisionally challenged * prisoners * \>4 doses of metronidazole for the treatment of c. difficile in the previous 7 days * \>4 doses of oral vancomycin in the previous 7 days

Keywords: recipients
feasibility of home based transcutaneous spinal cord stimulation for persons with sci

Conditions: Tetraplegia

Summary: the proposed study will focus on the feasibility of and effectiveness to a home-based program for persons with chronic sci focused on upper limb training augmented with a transcutaneous neurostimulator supported via a video telehealth platform.

the overarching goal of this study is to train participants with tetraplegia and their companion to operate a non-invasive surface applied neurostimulation unit (onward, arcex) while performing a prescriptive functional task based upper extremity home program for 2 months. participants will be supported with video-telehealth to assist with any difficulties that may arise and to progress their upper extremity home program. evaluations will assess the feasibility of this video telehealth supported model as measured by the ease of use of the technology (quest 2.0, nasa-tlx) as well as participants ability to attend and complete all the training visits. changes in upper extremity physical function will be measured using validated clinical tools (grassp, cue-q, dash, copm) as well as detailed evaluation of upper extremity muscle activation from surface emg and strength measurements of pinch and grasp. the primary outcome measure of this study is feasibility, and the secondary outcome measure is to capture changes in upper extremity performance.

Eligibility criteria:
inclusion criteria: 1. veteran 2. age 18-65 3. all gender, any ethnicity 4. cervical spinal cord injury c2-8 5. american spinal injury association (asia) impairment scale (ais) b, c or d 6. grassp-prehension score \>10 or grassp strength score \>30 7. greater than 1 year post injury 8. able to identify a companion to assist with neurostimulator setup in home environment. 9. internet connection to support video telehealth connection 10. willingness to travel to the va palo alto medical center exclusion criteria: 1. cardiopulmonary disease or cardiac symptoms, 2. autonomic dysreflexia that is uncontrolled or severe, 3. implanted medical device(s), 4. uncontrolled spasms that could limit participation in exercise training, 5. skin breakdown or active pressure injury in areas of electrode placement. 6. participants must not be engaged in any concurrent drug or device trial 7. pregnant, are planning to become pregnant, or breastfeeding 8. the study is not deemed safe or appropriate in the opinion of the investigators

Keywords: paralysis exercise telemedicine spinal cord stimulation physical activity
rct of cognitive therapy, paroxetine, combined ct and paroxetine and placebo

Conditions: Phobic Disorders

Summary: we aim to (1) evaluate the effectiveness of cognitive therapy and paroxetine and their combination, (2) investigate the patterns of change and the mechanisms of action involved during treatment by using psycho-physiological assessments in order to delineate some of the cognitive, behavioural and physiological mechanisms in the patients' response to ct, to paroxetine and placebo.one hundred patients with a primary diagnosis of social phobia will be selected and randomised into four treatment conditions. the first group (n=25) will be treated with ct alone, the second group (n=25) with ct plus paroxetine, the third group (n=25) with paroxetine and clinical management (tau), the fourth group will receive placebo and clinical management (n=25). all patients will have 12 weeks of treatment in the acute phase, which includes 12 sessions of individual treatment for the two first groups. the 2nd and 3rd groups will in addition have 12 weeks of drug treatment in the maintenance phase. the 4th group will have placebo for 24 weeks and clinical management. the patients will be assessed at pre-treatment, at 12 weeks and at the end of treatment of the acute phase (12 weeks) and by the end of maintenance phase (24 weeks). follow-up will be at 6 and 12 months. measures are based on all three main sources; self-report inventories, clinical assessments by independent raters and psycho-physiological assessments.


Eligibility criteria:
inclusion criteria: 1. signed written informed consent obtained prior to entry in the study. 2. diagnosed with primary social phobia, generalized or specific (dsm-iv, apa, 1994). 3. symptoms present at least one year. 4. age between 18-65 years. exclusion criteria: 1. known somatic diseases. 2. pregnant (\*) or lactating women. 3. psychosis 4. acute suicidal symptoms 5. major depressive disorder 6. generalized anxiety disorder or ptsd 7. cluster a or cluster b personality disorder 8. substance abuse or dependence 9. body dysmorphic disorder. 10. not willing to accept random allocation. 11. patients who take some form of ssri medications currently or during the last 6 months 12. patients not willing to withdraw psychotropic medication for a period of 4 weeks prior to entry to the trial or are taking herbal remedies that may be hazardous or inflict treatment response.

Keywords: phobic disorders therapy, cognitive paroxetine
very low calorie diet weight loss

Conditions: Obesity; Very Low Calorie Diet

Summary: understanding how foods and nutrients are digested, absorbed and metabolized when weight is stable and during weight loss induced by very low calorie diet procedure using the technologies of genomics, transcriptomics, proteomics, metabolomics and fluxomics ("omics") will enable generation of new hypotheses that could explain the inter-individual differences in weight loss and could lead to optimization and individualization of therapies designed to lose weight.

the overarching hypothesis is that there are baseline, pre- and post-diet combinations of 'omics' signatures in response to food and nutrients that explain the weight loss response of obese subjects to the very low calorie (vlc) diet. in order to address the general hypothesis the following specific aims will be addressed: specific aim 1: to test the hypothesis that there is a combination of 'omics' parameters in response to a defined meal that discriminate between morbidly obese subjects. specific aim 2: to test the hypothesis that variation in % weight loss to the 2-weeks of vlc diet is related to baseline genomic markers, gene expression profile, proteomic and metabolomic signatures as well as baseline metabolic and substrates fluxomics response to a defined meal. specific aim 3: to test the hypothesis that variation in % weight loss to the 4-weeks of vlc diet is related to baseline genomic markers, gene expression profile, proteomic and metabolomic signatures as well as baseline metabolic and substrates fluxomics response to a defined meal.

Eligibility criteria:
inclusion criteria obese subjects: diagnosed with morbid obesity (defined as bmi \> 40 kg/m2 or bmi \> 35 kg/m2 with at least one serious comorbidity (2013 nih compendium guidelines)) scheduled for medically supervised very low calorie diet age 30 years and older ability to lay in supine or elevated position for 5 hours willingness and ability to comply with the protocol exclusion criteria any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (for healthy control group only) participation in weight loss management program within the last 6 months prior the first study day presence of fever within the last 3 days untreated metabolic diseases including hepatic or renal disorder unrelated to the primary disease presence of acute illness or metabolically unstable chronic illness unrelated to the primary disease · (possible) pregnancy any other condition according to the pi or nurse that would interfere with the study or safety of the patient failure to give informed consent use of protein or amino acid containing nutritional supplements within 3 days of first test day
comparative effectiveness of palbociclib plus ai versus fulvestrant for hr+/her2- abc

Conditions: Hormone Receptor Positive Advanced Breast Cancer

Summary: a retrospective cohort study conducted at the cancer hospital chinese academy of medical sciences to compare the effectiveness of palbociclib plus ai therapy and fulvestrant monotherapy as initial endocrine therapy in the patients with hr+/her2- advanced breast cancer.

this study is designed to be a retrospective cohort study conducted at the cancer hospital chinese academy of medical sciences. the target populations of this study are patients with hr+/her2- advanced breast cancer who received the initial endocrine therapy of palbociclib plus ai or fulvestrant monotherapy from august 1, 2018 to december 31, 2020. it is expected to enroll 600 subjects in this study. the subjects' data such as demographics and other baseline characteristics, medications, prognosis, will be collected retrospectively, and statistical analysis of data will be conducted to compare the effectiveness outcome measures.

Eligibility criteria:
inclusion criteria: 1. chinese women ≥18 years old; 2. diagnosed with locally advanced (stage iiib/iiic) or metastatic (stage iv) breast cancer; 3. the molecular classification is pathologically confirmed as hr+/her2-; 4. palbociclib plus ai or fulvestrant monotherapy as initial endocrine therapy for advanced breast cancer for at least 1 cycle; 5. the follow-up time should be not less than 3 months after the start of palbociclib plus ai therapy or fulvestrant monotherapy. exclusion criteria: 1. subjects who have previously received chemotherapy, other cdk4/6 inhibitors or other endocrine monotherapy for advanced breast cancer.
acute effects of spirulina on postprandial glycemic responses and arterial blood pressure

Conditions: Potential Abnormality of Glucose Tolerance; Appetitive Behavior; Blood Pressure

Summary: this study investigated the effects of three doses of spirulina in glucose beverages on postprandial glycemic responses, arterial blood pressure, and subjective satiety.

this study aimed to determine the effects of three different doses (4, 6 and 8 g) of spirulina in glucose beverages on postprandial glycemic responses, blood pressure, and subjective appetite responses in healthy young adults.

Eligibility criteria:
inclusion criteria: * healthy * non-smokers * men and women * body mass index between 18 and 24.9 kg/m2 * normal blood pressure (systolic blood pressure \<120 mmhg and diastolic blood pressure \<80 mmhg) * normal fasting blood glucose concentrations (\<100 mg/dl) exclusion criteria: * medical conditions (e.g., cardiovascular diseases, diabetes mellitus, kidney or liver conditions, severe clinical depression, gastrointestinal disorders) * under medications known to affect glycemia (glucocorticoids, metformin, thiazide diuretics) * allergy to spirulina * pregnancy * lactation * competitive sports * alcohol abuse * drug dependency

Keywords: blood glucose responses blood pressure spirulina subjective appetite blood glucose concentrations
furosemide stress test predicting early graft function in kidney transplantation

Conditions: Kidney Function; Kidney Transplant; Complications; Delayed Graft Function

Summary: furosemide is an old drug that has been used frequently in the postoperative period of kidney transplantation, aiming to achieve adequate urine output. there is no previous study that directly evaluate the urine response to standardized dose of furosemide in the postoperative period. the objective is to measure the urine output after standardized dose of furosemide is delivered, as a biomarker to predict the graft function in perioperative period.


Eligibility criteria:
inclusion criteria: * deceased donor kidney transplantation at kcmh * informed consent is accepted exclusion criteria: * known allergy to furosemide * surgical complication of allograft * urgently needed for dialysis (refractory hypervolemia, uremic symptoms, and hyperkalemia)

Keywords: furosemide stress test kidney transplantation urine output perioperation delayed graft function
adaption and testing of the quality of life in short stature youth (qolissy) questionnaire for parents with children from 0-4

Conditions: Achondroplasia; Small for Gestational Age; Growth Hormone Deficiency

Summary: the aim of the study is the adaption, implementation and validation of the instrument for the investigation of the short stature specific quality of life (qolissy) for children (age 0-4 years) with achondroplasia (ach), small for gestational age (sga) and growth hormone deficiency (ghd) from a parental perspective.

the questionnaire is intended to be particularly applicable in clinical trials, with a focus on the impact of short stature and the physical functionality of those affected. the instrument will be further developed according to the "guidelines for pro instrument development". it should be practical in its application and interpretation and applicable in the international context. in addition, it will be investigated whether, from the parents' point of view, other instruments are suitable for measuring the quality of life of their short statured children. their preference regarding the instruments will be assessed so that a recommendation can be made as to which instruments are particularly suitable. a systematic literature review will be conducted to identify suitable instruments to measure the quality of life of short statured children aged 0 to 4. approximately 10-20 parents of 0-4 year old children with ach, ghd and sga will be recruited for the qualitative data collection (n = 30 to 60). the patients will be recruited through the bkmf (german association for people of short stature and their families). in order to test the psychometric properties of the instruments, approximately 30 parents (15 mothers / 15 fathers) of 0-4 year old children with ach, ghd and sga will be recruited for the quantitative part of the study (n = 90). all participants will be asked to complete the qolissy or other instruments found suitable in the pilot test. for the purpose of cross-validation, the pedsql will be used in parallel. two weeks after receiving the field test, the re-test will be sent to ensure the reliability of the study. the re-test will be administered to a minimum of 20% of the participants.

Eligibility criteria:
inclusion criteria: * parents of children aged 0-4 with the diagnosis achondroplaisa, short for gestational age or growth hormone defiency exclusion criteria: * other diagnosis than achondroplaisa, short for gestational age or growth hormone defiency * children older than 4 years of age

Keywords: health related quality of life
evaluating effective methods for referral for smoking cessation counseling and high blood pressure follow-up

Conditions: Hypertension; Smoking Cessation

Summary: investigators conducted a clinic-based study to determine the magnitude of uncontrolled hypertension and current smoking in eye doctor's offices and sought to determine if referral to care results in actions taken by the patient.

smoking and hypertension are two modifiable risk factors that are linked to highly prevalent chronic diseases such as diabetes and cardiovascular disease. the ophthalmology waiting room has the potential to be an effective point of intervention to provide referral to primary care in addition to health education on preventive health topics. the investigators therefore, conducted a clinic-based study to determine the magnitude of uncontrolled hypertension and current smoking in eye doctor's offices and to determine if referral to care results in actions taken by the patient. the investigators determined the proportion of patients who have elevated blood pressure. patients were referred appropriately and the proportion of participants who followed the recommendation to meet with their primary care doctor for elevated blood pressure at 4-6 weeks and 8-10 weeks was determined. in addition, those who consented to be in the study and admitted to smoking cigarettes were offered smoking cessation assistance through a quit line. investigators also followed up on cigarette smoking at 4-6 weeks and 8-10 weeks.

Eligibility criteria:
inclusion criteria: * patients \>18 years of age presenting to the glaucoma service and general eye service at wilmer eye institute. exclusion criteria: * non-english speakers * unable to provide written informed consent
babesia testing in blood donors

Conditions: Transfusion Transmitted Babesiosis

Summary: both prospective and retrospective (look back) study of blood donors for laboratory evidence of babesia microti infection. two laboratory methodologies will be utilized: 1. - pcr, to look for the presence of b.microti in whole blood 2. - ifa, to look for significant titers of b.microti antibody

retrospective study will involve archived specimens from blood donors whose units have already been released and transfused into recipients. prospective study will be real time and units testing positive by either pcr or ifa will be not released and will be disgarded, and the donors advised and deferred from further blood donation

Eligibility criteria:
inclusion criteria: * same as for donating blood exclusion criteria: * donor refusual to sign informed consent for this investigational babesia testing

Keywords: babesia blood donation transfusion transmitted babesiosis